Actively Recruiting
ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
Led by Enliven Therapeutics · Updated on 2025-07-01
21
Participants Needed
4
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
CONDITIONS
Official Title
ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BCR::ABL1 positive chronic phase chronic myeloid leukemia that has failed, or the patient is intolerant to, or is not a candidate for, at least 2 prior tyrosine kinase inhibitors (TKIs)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patient was born in Japan and both parents and grandparents are Japanese
- Adequate hematologic, hepatic, and renal function
- Prior bone marrow transplant allowed if at least 6 months before first dose of ELVN-001
You will not qualify if you...
- Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer
- History of acute TKI-related pancreatitis within 6 months before study entry
- Active chronic pancreatitis or pancreatic disease from any cause
- QTc greater than 470 milliseconds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Akita University Hospital
Akita, Akita, Japan
Actively Recruiting
2
Aiiku Hospital
Sapporo, Hokkaido, Japan
Actively Recruiting
3
The University of Osaka Hospital
Suita-shi, Osaka, Japan
Actively Recruiting
4
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Actively Recruiting
Research Team
Y
Yuzo Tomonaga
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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